09/24/2012

FDA to Industry: Stay Tuned to 2013 For Further Guidance On Federal Sample Disclosure Reporting

Section 6004 of the Patient Protection and Affordable Care Act (Act) requires manufacturers and
authorized distributors of record (ADRs) to disclose information related to
drug sample requests and distributions on or before April 1, 2012, and each
year thereafter. Earlier this year, the Food and Drug Administration (FDA)
issued a draft guidance for industry on the reporting of drug sample
distribution information. The FDA also issued the “ACA Industry Submission
Specifications User Guide,” which provides the technical requirements for the
proper submission of files through its Electronic Submissions Gateway (ESG).
During this time, the FDA also indicated that it did not intend to object until
at least October 1, 2012, if manufacturers and ADRs did not submit drug sample
information as required by the Act. The FDA has stated that it would provide
notice before it begins enforcing the drug sample reporting requirement. The
FDA also asked that interested parties submit comments and suggestions
regarding the draft guidance.

Today, the FDA
announced on its website that it is currently reviewing the comments it has
received regarding the draft guidance and the ESG, and that it “expects to
issue further guidance regarding its compliance policy, including the timing of
agency enforcement decisions, in early 2013.”

Please see the FDA website for additional information on the federal sample disclosure requirements.